HRP Services
Program Enhancement
Organizations frequently self-identify areas for improvement, or become aware because of an audit, inspection, or accreditation review, but need recommendations or assistance to address the issues at hand. Leveraging the extensive experience and expertise of our HRP consultants and network of research professionals, we can help you identify and implement the best solution for your organization.
IND Safety Reports and IRBs
HRP recently engaged in extensive correspondence with the FDA regarding the following statements that appeared in one of the later iteration’s of the FDA’s guidance document “Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency”:...
FDA Announces ClinicalTrials.Gov Enforcement Action
FDA recently announced enforcement action taken due to noncompliance with ClinicalTrials.gov requirements. While the enforcement action noted in the FDA announcement was directed at an industry sponsor, FDA made clear that responsible parties of all types, including...